All the comments about randomised trials are fair. Yes, you can (and probably should) do them in this population. Although to be fair the role for much radiotherapy is a bit light for evidence. Yes they will need to be done for FDA. Yes clinicians will want to see some done. Journals want randomised trials to publish.
But I have asked the CEO directly - twice - whether or not a randomised trial of any kind was specified, requested or expected for CE approval process.
The answer both times was an emphatic no.
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